MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	410-152
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was returned to the manufacturer, and was evaluated on 1 oct 2020 by a cross functional team.A 0.014 guidewire was fed through both the distal tip, and proximal end without issue.The device was patent the entire working length.The team was unable to replicate the patency complaint.However, an obvious breach to the outer jacket was seen 5cm from the distal tip, and extended 11cm towards the proximal end.No broken fibers were seen in the area of the breach.However, this evaluation now makes this event reportable due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
Event or Problem Description
A peripheral atherectomy procedure commenced, indication for procedure unavailable but information was requested.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.Initially, the complaint was that the device would not advance over a viper wire.A second turbo elite device was used to successfully complete the procedure with no reported patient harm.However, when the turbo elite catheter was returned to the manufacturer, and evaluated on 01 oct 2020, it was discovered that there was a breach in the device's outer jacket.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10692722
• Report Number: 1721279-2020-00212
• Device Sequence Number: 10838964
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)220604(10)FBD20E26A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD20E26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other